A Split-mouth Clinical Study on the Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Pain felt during treatment according to a visual analogue scale
研究概览
简要总结
The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed.
Design: a randomized split-mouth study with two-way repeated measures design.
详细描述
The intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in that small percentage of patients who may experience unpleasant sensations during caries removal. Laser analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp reactivity aiming for reduction of impulse formation of the pulpal nociceptors. It is based on the idea that parallel with the ablative high-energy level laser action, simultaneous low level laser therapy (LLLT) may occur. We hypothesize that when operating at pulse energies below the Er:YAG laser ablation threshold of tooth structure, the laser energy leads to loss of impulse conduction of type A-delta nerve fibers in the dental pulp, leading to an analgesic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- •Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents.
- •Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included.
- •Included are first molars which are not affected by hypoplasia or hypomineralization.
- •Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.
排除标准
- 未提供
结局指标
主要结局
Pain felt during treatment according to a visual analogue scale
时间窗: 1 hour
Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
次要结局
- Need for local anesthesia infiltration during the treatment(1 hour)
- Changes in pulpal sensibility to electrical stimuli by electrical pulp tester(25 minutes)
- Patient experience during analgesic or placebo procedure(5 minutes)
- Pain related behavior evaluated by the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale(1 hour)
- Dynamics of the heart rate of the patient(1 hour)
- Changes in pulpal sensibility to cold-stimuli by a visual analogue scale(25 minutes)